MAUDE Adverse Event Report: WAVELIGHT GMBH WAVELIGHT EX500 EXCIMER LASER; OPHTHALMIC EXCIMER LASER SYSTEM

Catalog Number 8065990794

Device Problem Device Displays Incorrect Message (2591)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Manufacturer Narrative

Investigation, including root cause analysis, is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.The manufacturer internal reference number is: (b)(4).

Event Description

A customer reported the system showed a shutter error and foot switch error.Additional information has been requested.

Manufacturer Narrative

During technical site visit, fse (field service engineer) verified system operation.A review of the device history record traceable to the reported serial number indicates that the product was processed and released according to the product¿s acceptance criteria.Fse replaced internal shutter.And performed system verification to specification as per sir(service installation record).Reported error indicates either a shutter motor or shutter light barrier problem.The root cause could not be determined conclusively.The manufacturer internal reference number is: (b)(4).

Manufacturer Narrative

A review of the device history record traceable to the reported serial number indicates that the product was processed and released according to the product¿s acceptance criteria.During technical site visit, fse (field service engineer) verified system operation.Fse (field service engineer) replaced internal shutter and performed system verification to specification as per sir (service installation record).Shutter received and failure investigation was performed.Visual inspection of the shutter shows no damages at the shutter and neither at the shutter flag nor micro switch.Functional inspection of the shutter on the system shows the reported messages during self test (fatal shutter and foot switch error).The reported issue could be reproduced by functional testing and malfunction could be confirmed.The root cause could not be determined conclusively.The manufacturer internal reference number is: (b)(4).

• Brand Name: WAVELIGHT EX500 EXCIMER LASER
• Type of Device: OPHTHALMIC EXCIMER LASER SYSTEM
• Manufacturer (Section D): WAVELIGHT GMBH; am wolfsmantel 5; erlangen 91058 ; GM 91058
• Manufacturer (Section G): WAVELIGHT GMBH; am wolfsmantel 5; erlangen 91058 ; GM 91058
• Manufacturer Contact: jonathan schlech ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8007579780
• MDR Report Key: 11785848
• MDR Text Key: 249982471
• Report Number: 3003288808-2021-00230
• Device Sequence Number: 1
• Product Code: LZS
• UDI-Device Identifier: 00380659907944
• UDI-Public: 00380659907944
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P020050
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 09/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/06/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 8065990794
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Manufacturer Received: 08/30/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/19/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1